NIH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Disinfectant, Subsystem, Water Purification
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Disinfectant intended for reprocessing water purification systems for hemodialysis.
- Adverse events (MAUDE)
- 2005: 3 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MINNCARE HD (K133724) | Medivators, Inc. | 2014-08-27 |
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Every clearance here is in the API, with alerts when new ones post.